1. EAST Master Class Series Live Webinar #2: REBOA Laura Moore, MD, FACS and Elizabeth Benjamin, MD, PhD, FACS Brought to you by the EAST Online Education Section

2. Generously sponsored by an unrestricted educational grant

3. Start Recording

4. REBOA Techniques, Indications, Pitfalls and Incorporating it in to your Trauma Program Elizabeth Benjamin MD, PhD, FACS Assistant Professor of Clinical Surgery LAC+USC Medical Center Laura J. Moore, MD, FACS Associate Professor of Surgery Chief of Surgical Critical Care Medical Director, Shock Trauma ICU

5. Introduction Hemorrhage remains a leading cause of death in civilian and wartime trauma Hemorrhage occurs in two broad categories: 1.Compressible 2.Non compressible Vascular disruption with concomitant hemorrhage is the leading cause of potentially preventable death in trauma patients

6. OBJECTIVES Overview of REBOA – Clinical indications – Zones of Occlusion Technical Considerations – 14 Fr and 7 Fr systems Potential Pitfalls Educational opportunities How to implement REBOA at your center

7. Statement of the Problem Hemodynamically unstable trauma patients with hemorrhage from the abdomen and pelvis have a high mortality rates. Failure to rapidly treat hemorrhage results in cardiovascular collapse and death.

8. Options for Aortic Occlusion 1. Resuscitative thoracotomy with application of aortic cross clamp.

9. Options for Aortic Occlusion 1.Resuscitative thoracotomy with application of aortic cross clamp. 2.Insertion of catheter into the aorta with inflation of a balloon to occlude lumen of the aorta.

10. What is REBOA? Resuscitative Endovascular Balloon Occlusion of the Aorta

11. Similarities and Differences Resuscitative ThoracotomyREBOA Maximally InvasiveMinimally Invasive High potential for blood exposure via accidental puncture to healthcare team Lower risk for blood exposure via accidental puncture to healthcare team Aortic Occlusion via Cross clamping Aortic Occlusion via Endovascular Balloon Supports myocardial and cerebral perfusion Allows access to other mediastinal structures (pericardium, heart, hilum) Allows for selective occlusion (Zone I vs. Zone III)

12. How 1. Arterial access s 2. Balloon selection & positioning 3. Balloon inflation 4. Balloon deflation 5. Sheath removal

13. Aortic Occlusion Zones Zone I – Descending thoracic aorta from origin of left subclavian to celiac Zones II – Paravisceral aorta between celiac and lowest renal artery Zone III – Infrarenal abdominal aorta to bifurcation

14. Aortic Occlusion Zones Select zone of occlusion based upon injury pattern Zones I and III preferred Avoid occlusion in Zone II Confirm zone of occlusion on plain x ray or fluoroscopy

15. REBOA Algorithm

16. REBOA - Patient Selection Refractory hemorrhagic shock due to non- compressible truncal hemorrhage – Penetrating abdominal trauma – Blunt trauma

17. REBOA - Patient Selection Refractory hemorrhagic shock due to non- compressible truncal hemorrhage – Penetrating abdominal trauma – Blunt trauma Resuscitative thoracotomy should still remain standard for patients with cardiovascular collapse from intra- thoracic hemorrhage

18. Case Example 24 year old male sustained a gunshot wound to the right upper quadrant. On arrival in the ER he was in extremis with a systolic blood pressure of 50 mm Hg and a heart rate of 135. Two large bore peripheral IVs were in place. Abdominal FAST exam was positive. Massive transfusion protocol was initiated. The OR was notified.

19. KUB in ER

20. Case continued The patient remained hypotensive with a systolic blood pressure in the 50’s. Given his positive abdominal FAST the decision was made to place a REBOA in Zone 1. The right common femoral artery was accessed percutaneously and a 14 French sheath was placed. The CODA catheter was inserted and the balloon was inflated in Zone 1.

21. Zone 1 REBOA

22. Operative Details Massive hemoperitoneum Grade V right renal injury with active arterial hemorrhage from the hilum -> right nephrectomy performed Bullet lodged in the vertebral body with ongoing hemorrhage -> patient underwent angioembolization of lumbar artery Right groin cutdown performed, sheath removed, common femoral artery repaired

23. Hospital Course Admitted to STICU post op Taken back in 24 hours for abdominal closure Discharged to rehab facility on post operative day 12

24. Zone 3 REBOA

25. REBOA Placement Technique 14F System7F System

26. REBOA Technique Femoral Arterial Access 7F Sheath Placement Wire exchange Upsize sheath 14F 14F System 7F System Float REBOA Wireless

27. Arterial Access Sheath Introducer Measure Catheter Stiff Wire Upsize Sheath REBOA Insertion Inflate Balloon

28. Arterial Access Sheath Introducer Measure Catheter Stiff Wire Upsize Sheath REBOA Insertion Inflate Balloon

29. Arterial Access Sheath Introducer Measure Catheter Stiff Wire Upsize Sheath REBOA Insertion Inflate Balloon

30. Arterial Access Sheath Introducer Measure Catheter Stiff Wire Upsize Sheath REBOA Insertion Inflate Balloon

31. Arterial Access Sheath Introducer Measure Catheter Stiff Wire Upsize Sheath REBOA Insertion Inflate Balloon

32. Arterial Access Sheath Introducer Measure Catheter Stiff Wire Upsize Sheath REBOA Insertion Inflate Balloon

33. Arterial Access Sheath Introducer Measure Catheter Stiff Wire Upsize Sheath REBOA Insertion Inflate Balloon

34. Arterial Access Sheath Introducer Measure Catheter Stiff Wire Upsize Sheath REBOA Insertion Inflate Balloon

35. Arterial Access 7F Sheath Placement Wireless Catheter Insertion

36. Arterial Access Sheath Introducer Measure Catheter Stiff Wire Upsize Sheath REBOA Insertion Inflate Balloon

37. Arterial Access Sheath Introducer Measure Catheter Stiff Wire Upsize Sheath REBOA Insertion Inflate Balloon

38. Arterial Access Sheath Introducer Measure Catheter Stiff Wire Upsize Sheath REBOA Insertion Inflate Balloon

39. Catheter Measurement External landmarks X-ray verification Fluoroscopy

40. Catheter Measurement External landmarks X-ray verification Fluoroscopy Cadaver based study Mid-Sternum as external landmark 100% Balloon deployed in landing zone (I)

41. LAC+USC REBOA Patient Selection Refractory hemorrhagic shock Failed aggressive ED resuscitation Anticipated operative intervention Anticipated occlusion time <30min Liberal thoracotomy for cardiac arrest

42. REBOA Patient Selection Significant Intra-Abdominal Injury Burden

43. Cardiac Arrest Extremity Trauma Abdominal Trauma Thoracic Trauma Thoracotomy Tourniquet REBOA Ongoing Resuscitation

44. Cardiac Arrest Extremity Trauma Abdominal Trauma Thoracic Trauma Thoracotomy Tourniquet REBOA Hypotension refractory to resuscitation Temporary maneuver Imminent operative intervention Delay hypovolemic cardiac arrest Hypotension refractory to resuscitation Temporary maneuver Imminent operative intervention Delay hypovolemic cardiac arrest Ongoing Resuscitation

45. Pelvic Bleeding Candidate for Zone 3 Occlusion

46. Severe Pelvic Fracture (PXR) Hypotension Severe Pelvic Fracture (PXR) Hypotension +/- REBOA Operating Room Interventional Radiology Refractory Hypotension Volume Responsive Volume Responsive Resuscitation

47. REBOA Indication Summary Hemodynamic Instability Abdominal or Pelvic Trauma Bridge to operative intervention Not used in cardiac arrest

48. REBOA Program: Key Elements 1Identify hospital resources – Interventions/Complications 2Clear understanding of patient selection – Surgeon driven 3Training program – Initial training – Skill maintenance 4Patient Safety/Quality Improvement

49. REBOA Training Centralized Training – Standardized approach – Certificate upon completion – Hospital credentialing Internal Institution-Specific Training – Training tailored to specific needs of participants and hospital resources – Availability of refresher training

50. REBOA Training LAC+USC Didactic Sessions –Literature review –Procedure indications –Potential pitfalls Catheter System Familiarity Perfused Cadaver Sessions Case Analysis

51. REBOA Training LAC+USC FTDL Arterial and Venous Perfusion Perfusion Pump and Drainage

52. CODA Placement: 14F catheter

53. ER REBOA: 7 Fr Catheter

54. Zone 3 Positioning

55. Distal Aortic Disruption

56. Hemodynamic Response

57. Potential Pitfalls Catheter Placement – Patient selection No benefit to patient Delay in treatment – Zone 2 inflation Intestinal ischemia – Vascular injury Arterial dissection/transection Thrombosis

58. Potential Pitfalls Catheter Removal – Hematoma – Complicated arterial repair – Arterial dissection or thrombosis – Embolic event – Limb loss

59. Complications: Sheath Removal

60. Series of 24 REBOA cases from Japan (single center, over 6 years) Reported 3 lower extremity amputations from REBOA insertion 10 French Sheath used Procedure performed by ER doctors or Surgeons SHOULD WE ABANDON REBOA???

61. Presented at 2016 MHSRS Purpose: Evaluate vascular related complications related to REBOA insertion at the Texas Trauma Institute Methods: Retrospective review Operative details, outcomes *14 Fr Sheath & CODA balloon used in all cases

62. RESULTS Total number of patients33 Median Age47 (IQR 26.5-62.5) % male79 % blunt mechanism88 % percutaneous access of CFA55

63. VASCULAR COMPLICATIONS No amputations attributed to REBOA 21 of 33 patients survived to sheath removal – 13 (62%) underwent primary repair of CFA – 8 patients required additional vascular interventions 3 thrombectomy alone 2 thrombectomy + repair of dissection flaps + patch angioplasty 1 thrombectomy + patch angioplasty 1 thrombectomy + interposition graft + prophylactic fasciotomy 1 thrombectomy + repair of dissection flap

64. Basic Endovascular Skills for Trauma

65. BEST Course Currently offered in Baltimore and Houston ACS verified course For more information about BEST contact: Baltimore: BEST@umm.eduBEST@umm.edu Houston: laura.j.moore@uth.tmc.edulaura.j.moore@uth.tmc.edu

66. Questions? laura.j.moore@uth.tmc.edu Elizabeth.Benjamin@med.usc.edu

67. Confidential Information 1 www.prytimemedical.com David Spencer – President/CEO Roger Baker – SVP, Global Sales & Marketing Customer Service: 210-340-0116